GE Senographe Pristina systems recalled for collimator nonconformance
GE HealthCare found a nonconformance in certain Senographe Pristina VIA systems. In 3D+2D manual mode, when the anode track and filter combination is configured differently, collimator blades might be visible in the image, the collimator might open more than expected, or an incorrect collimator filter might be used for the selected anode track. This could deliver a minor additional X-ray dose to the patient and cause obvious image artifacts.
From the FDA notice · Read the official notice ↗ · All GE recalls
What to do
- The notice does not specify a remedy; contact GE HealthCare for guidance on affected Senographe Pristina VIA systems.
- Identify affected systems using the GTINs listed in the notice, such as 00840682118460 and 10195278901764.
- Note that the issue applies in 3D+2D manual mode when the anode track and filter configuration is different.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Senographe Pristina
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 3 products — see all of them.
Details
- Illnesses reported
- None reported
- Manufactured in
- 3000 N Grandview Blvd, Waukesha, Wisconsin, United States
- Classification
- Class II
- Recall number
- Z-0327-2027
In the FDA's words
- Description
- Senographe Pristina GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisition configuration of the anode track/filter combination is different, it can result in the following: the collimator blades might be visible in the image, or the collimator might be open more than expected, and an incorrect collimator filter might be used with respect to the anode track selected This issue could result in a minor additional X-ray dose being delivered to the patient and obvious artifacts in the image (collimator blades). GTIN(s): 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026, 00198953109281, 10198953054311, 10195278901764. Distribution: USA and OUS.
- Hazard
- GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisition configuration of the anode track/filter combination is different, it can result in the following: the collimator blades might be visible in the image, or the collimator might be open more than expected, and an incorrect collimator filter might be used with respect to the anode track selected This issue could result in a minor additional X-ray dose being delivered to the patient and obvious artifacts in the image (collimator blades).
3 products in this recall
The agency lists each product separately. Check every one you might have.
- Senographe PristinaZ-0326-2027
- Senographe Pristina (this page)Z-0327-2027
- Senographe Pristina 3DZ-0328-2027